Reagent Set A 8002163

GUDID 07332699000331

Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol mounted in a cassette.

M DIALYSIS INC.

Microdialysis system
Primary Device ID07332699000331
NIH Device Record Keyb4f47e97-1a9e-4fd8-afcb-af774f38a979
Commercial Distribution StatusIn Commercial Distribution
Brand NameReagent Set A
Version Model NumberReagent
Catalog Number8002163
Company DUNS824632087
Company NameM DIALYSIS INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107332699000331 [Primary]

FDA Product Code

PPMGeneral Purpose Reagent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-07
Device Publish Date2016-09-24

Devices Manufactured by M DIALYSIS INC.

07332699000300 - Reagent Kit2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol.
07332699000331 - Reagent Set A2019-10-07Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol mounted in a cassette.
07332699000331 - Reagent Set A2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol mounted in a
07332699000348 - Reagent Set B2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate, Glycerol and Glutamate m
07332699000355 - Reagent Set C2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate and Pyruvate mounted in a cassette.
07332699000461 - Calibrator A2019-10-07 Calibrator for ISCUSflex Microdialysis Analyzer. Contains calibrator levels for Glucose, Lactate, Pyruvate, Glycerol and Glutama
07332699000744 - ISCUSflex2019-10-07 Microdialysis analyzer using substance specific reagents to evaluate the concentrations in the samples given by the Microdialysi
07332699000621 - L-P-G Reagent kit2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate and Pyruvate.
07332699000546 - 70 Brain Microdialysis Catheter 60/10, 4/pkg2019-10-07 Microdialysis catheter (20 kDa cut-off, 60 mm shaft length, 10 mm membrane length) for short term brain insertion using a tunnel

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